Behavior, Health, Cardiovascular Diseases, Health Knowledge, Attitudes, Practice, Heart Diseases
Conditions
Keywords
Cardiac Rehabilitation, Women's Health, Patient Education, Cardiovascular Disease Prevention, Secondary Prevention, Health Education, Women-Focused Care, Gender-Specific Care, Digital Health / Virtual Care, Self-Management, Health Behaviour Change, Quality of Life, Feasibility Study, Pilot Randomized Controlled Trial
Brief summary
The goal of this pilot clinical trial is to learn if a women-focused education program can improve knowledge, health, and well-being in women with heart disease who are attending cardiac rehabilitation. It will also help researchers understand if this program can be delivered successfully in different rehabilitation programs. The main questions it aims to answer are: * Is it feasible to deliver this women-focused education program within routine cardiac rehabilitation programs? * Do women who receive this program show improvements in heart health knowledge, quality of life, and healthy behaviours? Researchers will compare women who receive the Cardiac College for Women program plus usual cardiac rehabilitation to those who receive usual cardiac rehabilitation alone to see if the program leads to better outcomes. Participants will: * Be randomly assigned to receive either the women-focused education program or usual care * Attend cardiac rehabilitation as part of their regular care * Complete questionnaires at the start and end of the program * (If in the intervention group) attend online education sessions and use supporting materials * (Optional) take part in a group discussion about their experience after completing the program
Detailed description
Cardiovascular disease remains the leading cause of death among women worldwide. Despite strong evidence supporting the benefits of cardiac rehabilitation, women are less likely than men to be referred, enroll, and complete these programs. Multiple barriers contribute to this gap, including caregiving responsibilities, work demands, limited awareness of benefits, and psychosocial challenges. In addition, most cardiac rehabilitation programs provide standardized, mixed-gender education that does not address sex- and gender-specific aspects of cardiovascular disease. As a result, important topics relevant to women - such as unique risk factors, symptom presentation, and psychosocial experiences - may be underrepresented. Patient education is a central component of cardiac rehabilitation and plays a key role in improving disease knowledge, supporting self-management, and promoting healthy behaviours. Evidence suggests that tailored education may enhance engagement and better meet the needs of specific populations. Women-focused cardiac rehabilitation approaches have shown promise in improving satisfaction, adherence, and patient-centred outcomes; however, access to structured, evidence-based educational programs designed specifically for women remains limited. Cardiac College for Women is a women-tailored educational program developed to address these gaps. It is based on established patient education principles and health behaviour theories and was created through an iterative process incorporating research evidence, clinical expertise, and input from women with lived experience of cardiovascular disease. The program is designed to be delivered remotely alongside routine cardiac rehabilitation, offering flexibility and addressing common barriers to participation such as time constraints and transportation. Preliminary research has demonstrated that women participating in this program show improvements in disease-related knowledge, quality of life, and health behaviours, along with high levels of satisfaction and engagement. However, prior evaluations have not used a randomized design, and further research is needed to determine whether the program can be implemented effectively across different settings and integrated into routine care. The purpose of this study is to evaluate the feasibility of conducting a multicentre randomized controlled trial of Cardiac College for Women within cardiac rehabilitation programs. This includes assessing the ability to recruit and retain participants, deliver the intervention as intended, and collect study data across sites. In addition, the study will explore how women and healthcare providers experience the program and its integration into clinical practice. This pilot randomized controlled trial will compare a women-focused education program delivered alongside usual cardiac rehabilitation to usual cardiac rehabilitation alone. The study is designed to generate important feasibility data and preliminary insights that will inform the design of a larger, definitive trial. Ultimately, this research aims to support the development of more inclusive, gender-responsive cardiac rehabilitation models and improve access to tailored education for women with cardiovascular disease.
Interventions
Cardiac College for Women is a structured, women-focused cardiovascular education program delivered online during participation in cardiac rehabilitation. It consists of 12 sessions (60 minutes each) covering sex- and gender-specific cardiovascular risk factors, healthy lifestyle behaviours, psychosocial well-being, and self-management strategies. Sessions include presentations, videos, and interactive discussions facilitated by trained cardiac rehabilitation staff. Participants also receive tailored educational materials relevant to their cardiac condition and complete a reflection diary to support learning and behaviour change. The program is delivered remotely to improve accessibility and complement usual cardiac rehabilitation care.
Standard cardiac rehabilitation education delivered as part of routine care. This includes group-based sessions covering cardiovascular risk factors, lifestyle modification, medication management, and secondary prevention. Sessions are typically delivered in mixed-gender groups and are not specifically tailored to women's cardiovascular health needs. Participants also receive supervised exercise and multidisciplinary support as part of comprehensive cardiac rehabilitation.
Sponsors
Study design
Masking description
Due to the nature of the educational intervention, participants and care providers cannot be blinded to group allocation. Outcome data are primarily collected through self-reported questionnaires. Data analysis will be conducted using coded group assignments where feasible to minimize bias.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel groups: (1) Cardiac College for Women plus usual cardiac rehabilitation, or (2) usual cardiac rehabilitation alone. The intervention is delivered over the duration of the cardiac rehabilitation program, and outcomes are assessed at baseline and at program completion. The study includes an embedded mixed-methods process evaluation to assess feasibility, implementation, and acceptability across sites.
Eligibility
Inclusion criteria
* Identify as a woman * Aged 18 years or older * Enrolled in a participating cardiac rehabilitation program * Diagnosis consistent with cardiac rehabilitation eligibility (e.g., coronary artery disease, myocardial infarction, revascularization procedures, spontaneous coronary artery dissection, myocardial infarction with non-obstructive coronary arteries, Takotsubo cardiomyopathy, or heart failure) * Able to provide informed consent * Able to participate in educational sessions in English or French (site-dependent)
Exclusion criteria
* Medical, cognitive, or psychiatric conditions that would prevent participation in educational sessions or completion of study questionnaires * Inability to access or use online educational sessions or digital materials required for the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of delivering a women-focused education program within cardiac rehabilitation | Baseline to end of cardiac rehabilitation (approximately 12-16 weeks) | Feasibility will be assessed using multiple indicators, including recruitment rate (proportion of eligible participants enrolled), retention rate (proportion completing follow-up assessments), intervention adherence (attendance at education sessions), intervention fidelity, and completeness of outcome data collection. These measures will determine whether a larger randomized controlled trial is practical and achievable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart-health behaviours | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) | Assessed through a combination of measures including physical activity (step counts), adherence to a Mediterranean-style diet, medication adherence, and self-reported lifestyle behaviours. |
| Health-related quality of life | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) | Measured using the MacNew questionnaire, which assesses physical, emotional, and social aspects of quality of life in individuals with cardiovascular disease. |
| Implementation and acceptability of the intervention | End of cardiac rehabilitation (approximately 12-16 weeks) | Assessed through participant engagement with sessions and materials, and perceptions of relevance, usefulness, and accessibility. Healthcare provider perspectives on feasibility and integration into routine practice will also be explored using qualitative interviews and focus groups. |
| Disease-related knowledge | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) | Measured using the Coronary Artery Disease Education Questionnaire - Short Version (CADE-Q SV), a validated tool assessing knowledge across domains including medical condition, risk factors, exercise, nutrition, and psychosocial health. |
| Functional capacity | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) | Measured using the Duke Activity Status Index (DASI), a self-reported questionnaire assessing the ability to perform daily physical activities. |
Countries
Canada
Contacts
University Health Network, Toronto